Short-term Health Benefits of Using Fresh Air Filtration System in Classroom

March 28, 2019 updated by: Zhuohui Zhao, Fudan University

Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools

A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air system with no filtration and 3) natural ventilation. Each arm is going to be in use for five continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross over change between 3 arms is going to be taked. Then the 2nd week of intervention is performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is going to be repeated again until each classroom will be applied by all three arms of ventilation. A total of 5 weeks is required for the project. Children's biological samples including saliva, urine and skin samples will be collected as well as exhaled NO. A questionnaire on children's perception on air quality will be assessed as well.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All invited primary school children in Grade 5 in an artibrarily selected school

Exclusion Criteria:

  • Current airway symptoms (cough, airway infection, asthma et al.)
  • Acute infectious diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fresh air system with filtration
A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom.
Device: Fresh air system with filtration
Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms
Other Names:
  • mechanical ventilation and filtration system
Placebo Comparator: Fresh air system with no filtration
A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom.
Device: Fresh air system with filtration
Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms
Other Names:
  • mechanical ventilation and filtration system
No Intervention: Natural ventilation
Natural ventilation system was applied in the 3rd classroom as normal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exhaled nitric oxide
Time Frame: within 2 hours of the end of intervention in each week
Airway inflammation biomarker
within 2 hours of the end of intervention in each week
Oxidative stress biomarkers
Time Frame: within 2 hours of the end of intervention in each week
The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.
within 2 hours of the end of intervention in each week
Sick building symdrom
Time Frame: within 2 hours of the end of intervention in each week
Answering questionnaire on sick biulding symdrom
within 2 hours of the end of intervention in each week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Chair: Zhuohui Zhao, Dr, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2018

Primary Completion (Actual)

January 20, 2019

Study Completion (Actual)

January 22, 2019

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XFGY001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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